Container, nebulizer and use

ABSTRACT

A container, a nebulizer and a use of an indicator device are described, where the container comprises an indicator device fixedly mounted on the bottom of the container, the container is arranged within the nebulizer and the container can be detached by grabbing the indicator device.

BACKGROUND

The present invention relates to a container, to a nebulizer, and to ause of an indicator device.

WO 2012/162305 A1 discloses a nebulizer. A container can be insertedinto a housing of the nebulizer. The housing is closed by a lowerhousing part. By rotating the housing part the drive spring can be putunder tension and fluid can be sucked into a compression chamber of thepressure generator. Simultaneously, the container is moved into thelower housing part in a stroke movement within the nebulizer and whentensioned for the first time the container may be pierced through itsbase by a piercing element in the lower housing part to allow venting ofthe container. After manual pressing a button, the drive spring isreleased and moves the delivery tube into the pressure chamber so thatthe fluid is put under pressure by the drive spring and is delivered oratomized through a nozzle into a mouthpiece as an aerosol, without theuse of propellant gas. Thus, the container is moving axially forth andback during conveying of the fluid to be nebulized, and during pressuregeneration and nebulization.

The container may be connected inseparably with the housing part by asecuring device forming a transportation lock for holding the containerunmovable in a delivery state.

The nebulizer comprises an indicator device for counting and/orindicating a number of uses performed or still possible. The indicatordevice blocks further use in a locked state when a predetermined numberof uses has been reached or exceeded with the current container. Then,the container can be replaced together with a housing part and thenebulizer can be used further with the new container.

U.S. Pat. No. 7,823,584 B2 discloses a similar nebulizer, wherein acounter device can be integrated into a housing part that isexchangeable or replaceable together with the container, which isinseparable from the housing part.

WO 2007/104694 A1 discloses an inhaler for powdery substances with anindicator device which may comprise a worm gear for driving an indicatorelement.

SUMMARY OF THE INVENTION

Object of the present invention is to provide a nebulizer and acontainer for a nebulizer as well as a use of an indicator deviceallowing easy and/or secure operation and handling and/or a compactand/or reliable construction, preferably while allowing replacement ofthe container without replacement of any housing part of the nebulizer.

The above object is achieved by a container as described and claimedherein, or by a nebulizer as described and claimed herein or by a use orby a method both as described and claimed herein.

The present invention relates to a nebulizer for nebulizing a fluid,preferably liquid medicament, from a replaceable container containingthe fluid, and relates to the container. Preferably, an indicator deviceis provided for counting and/or indicating the number of uses alreadyperformed or still possible with the container.

In particular, the indicator device or an associated locking device canlock the container and/or nebulizer or can cause the locking of thecontainer and/or nebulizer against further use in a locked state when apredetermined number of uses has been reached or exceeded with therespective container.

Preferably, the nebulizer comprises a housing part which can be detachedfrom the nebulizer or opened for replacing the container.

Preferably the nebulizer and/or container cannot be used anymore in thelocked state when the indicator device has detected that a predeterminednumber of uses has been reached or exceeded, in particular with therespective container.

Preferably, the locking of the nebulizer against further use can beovercome by replacing the container, in particular including theindicator device, against one not yet used.

The indicator device is preferably inseparably connected with thecontainer or with a container housing of the container, but separablefrom the nebulizer or its housing and from the housing part, so that theindicator device is replaceable together with the container. This allowsreuse of the nebulizer and the housing part with another containerincluding another indicator device. Thus the overall size of thecomponents to be exchanged is kept small, so that the replacementpackages are size reduced, so that transport of a large number ofpackages is facilitated.

Preferably, the indicator device or its housing is fixedly orinseparably arranged at a bottom of the container and/or opposite to anoutlet of the container. This allows a very compact construction.Further, the indicator device does not interfere with the fluidicconnection of the container to the nebulizer or vice versa.

Preferably, the indicator device or its housing is connected to orsecured at the container or its housing by snapping, clamping, gluing,screwing, hot pressing, welding, in particular ultrasonic forming orwelding, or the like.

In particular, the connection between the housing of indicator deviceand the container is a direct connection wherein a form-fit connection(positive connection) and/or a frictional connection (i.e. “force-fit”or non-positive connection) is achieved. A direct connection can berealized in particular by respective inter-engagement of the containerhousing or its edge on one hand and the indicator housing or arespective gripping section or collar on the other hand. Preferably thegripping section or collar of the indicator housing engages with aprotruding edge or with indentions on the housing of the container. Forinstance, the direct connection can be achieved by cold-forming orsnap-fit or hot crimping/peripheral flanging. In particularly, theindicator housing and the container housing can be connected bydeforming the gripping section or collar of the indicator housing sothat it engages with the housing of the container, i.e. by forming orbending the gripping section over a protrusion and/or into an indentionat the housing of the container. Preferably a tool is used for formingor bending the collar or the gripping section, whereby the tool is movedlongitudinally over the container towards the container base, edgeand/or gripping section and/or a connection area, in particular whereinthe tool comprises a preferably conical end section for forming thecollar or gripping section towards the container and/or radiallyinwardly.

The deformation of the collar or gripping section is preferably achievedby crimping/peripheral flanging (preferably using an input of heat)preferably wherein by means of the forming tool electric or inductiveand/or mechanical energy is employed. For instance, the gripping sectionor collar can be deformed in a hot stamping process employing anelectrically heated hot bar or in a process using ultrasonic excitationof longitudinal and/or torsional vibrations within the material(preferably a plastic) of the gripping section or collar.

Alternatively, the connection between the housing of indicator deviceand the container may be an indirect connection wherein the indicatordevice and the container are connected by means of an (additional)connection element. With the connection element, the achieved connectionmay be a form-fit connection and/or a force-fit connection and/or ansubstance-to-substance bond (for instance achieved by gluing orwelding). For instance, the connection element may be a tubular partwhich is cold-formed/crimped or heat shrunk onto the containerhousing/edge of the container and the indicator housing so that theindicator device and the container are fixed to each other along thelongitudinal axis. Alternatively the connection element may be aspreadable part or radial flexible part like a retaining ring orspring-lock washer which connects the container housing and theindicator housing by (partial) spreading in between them. Alternatively,the connection element may be (injection) molded onto the housing of thecontainer and/or the indicator housing.

Preferably, the indicator device or its housing is attached to thecontainer or its housing such that the indicator device is securedagainst rotation relative to the container. This non-rotationalsecurement or anti-twist securement allows or facilitates detachment orchange of the container by rotating the indicator device or its housing.

The securement against relative rotation is preferably achieved byform-fit engagement. The securement can be realized in particular byrespective inter-engagement of the container housing or its edge on onehand and the indicator housing or a respective gripping section on theother hand. However, any other suitable connection, such as a connectionby force-fit, can be used to achieve the preferred securement againstrelative rotation of the indicator device or its housing with thecontainer or its housing.

Preferably, the indicator device or its housing or a gripping portion isconnected to or with the container such that a user can detach—inparticular more easily—the container from the housing by grabbing theindicator device, its housing or the gripping portion, in particular byaxially pulling and/or rotating the indicator device or its housing, sothat the container is detached or detachable from the associatednebulizer. In particular, the combination of rotating the indicatordevice and, thus, the container, during axially pulling allows a lowerforce to detach the container from the nebulizer or its holder,preferably in consideration of the gliding forces (e.g. betweencontainer and nebulizer or holder and/or between container and conveyingtube) than the effective holding forces without relative movement, i.e.without relative rotation between container and nebulizer. Thisfacilitates in particular detachment and/or change of the container.

Preferably, the container is attached or attachable with its head and/orits side or end opposite to the indicator device to the nebulizer or aholder of the nebulizer.

Preferably, the container is attached or attachable to the nebulizer bysnap-fit, in particular, a head or end of the container is connected orconnectable with a holder (preferably within the nebulizer) by snap-fitor clamping.

Preferably, the indicator device or its housing comprises a grippingportion, in particular such as a flattening, indention, protection orriffle, so that a user can easily and/or securely grab and hold theindicator device, in particular for rotating and/or axially pulling theindicator device and, thus, the container connected with the indicatordevice. This facilitates the handling and operation.

Preferably, the indicator device or its housing or the gripping portionforms a detachment or removal tool or aid or is used as such.

Independently from the provision of the indicator device, a grippingportion may be provided and/or connected with the container or itshousing, in particular at the lower end or base of the container, inparticular as indicator device or instead of the indicator device, inorder to facilitate detachment of the container as described above. Inthis case, the gripping portion may have a similar form, in particularan at least essentially cylindrical form, as the indicator housing or adifferent form. The connection of the gripping portion and container isrealized preferably as described for the indicator device and container.

The above aspects of the present invention and the further aspectsdescribed below can be realized independently from each other, and inany combination.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages, features, characteristics and aspects of the presentinvention will become apparent from the claims and the followingdescription of a preferred embodiment with reference to the drawings. Itshows:

FIG. 1 a schematic section of a known nebulizer in a non-tensionedstate;

FIG. 2 a schematic section, rotated 90° compared with FIG. 1, of theknown nebulizer in a tensioned state;

FIG. 3 a schematic section of a nebulizer with an inserted container ina non-tensioned state according to a preferred embodiment of the presentinvention;

FIG. 4 a partial enlargement of the encircled part of FIG. 3;

FIG. 5 a perspective view of the section of the nebulizer according toFIG. 3;

FIG. 6 an enlargement of the encircled part of FIG. 5;

FIG. 7 a schematic exploded view of an indicator device according to apreferred embodiment of the present invention;

FIG. 8 an axial section of the indicator device in an actuated state;

FIG. 9 an axial section of the indicator device in a locked state;

FIG. 10 a perspective section of the indicator device in an actuatedstate;

FIG. 11 a perspective section of the indicator device in a releasedstate;

FIG. 12 a partial enlargement of the nebulizer similar to FIG. 4, but ina partially tensioned state;

FIG. 13 a partial enlargement of the nebulizer similar to FIG. 4, but ina fully tensioned state;

FIG. 14 a partial section of the nebulizer similar to FIG. 4, but in anintermediate state during a dispensing stroke;

FIG. 15 a partial section of the nebulizer similar to FIG. 4, but withan indicator device of the container in a locked state;

FIG. 16 a schematic section of the nebulizer in the locked state afternext tensioning with partially opened housing part and with lockedlocking device;

FIG. 17 a partial enlargement of the encircled part of FIG. 13;

FIG. 18 a schematic section of the nebulizer similar to FIG. 3 withunlocked locking device;

FIG. 19 a schematic section of the indicator device in the initial stateaccording to a modified embodiment;

FIG. 20 a perspective section of the indicator device according to FIG.19;

FIG. 21 a partial section of the container with the associated indicatordevice with undeformed gripping section;

FIG. 22 a partial section of the container with the associated indicatordevice with deformed gripping section;

FIG. 23 a perspective view of the container and separated indicatordevice;

FIG. 24 a radial section of the container with the indicator device ofFIG. 22 in the region of the gripping section; and

FIG. 25 a side view of the container with the associated indicatordevice for showing a gripping portion.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the Figures, the same reference numerals are used for identical orsimilar parts, resulting preferably in corresponding or comparableproperties and advantages, even if the associated description is notrepeated.

FIGS. 1 and 2 show a known nebulizer 1 for atomizing a fluid 2,particularly a highly effective pharmaceutical composition, medicamentor the like, diagrammatically shown in a non-tensioned state (FIG. 1)and in a tensioned state (FIG. 2). The nebulizer 1 is constructed inparticular as a portable inhaler and preferably operates only mechanicaland/or without propellant gas.

When the fluid 2, preferably a liquid, more particularly apharmaceutical composition, is nebulized, an aerosol 14 (FIG. 1) isformed or dispensed, which can be breathed in or inhaled by a user.Usually the inhaling is done at least once a day, more particularlyseveral times a day, preferably at set intervals, depending on thecomplaint or illness from which a patient is suffering.

The nebulizer 1 is provided with or comprises an insertable orreplaceable container 3 containing the fluid 2. The container 3 thusforms a reservoir for the fluid 2, which is to be nebulized. Preferably,the container 3 contains multiple doses of fluid 2 or active substancein particular sufficient to provide up to 200 dosage units or doses, forexample, i.e. to allow up to 200 sprays or applications. A typicalcontainer 3, as disclosed in WO 96/06011 A1, holds e.g. a volume ofabout 2 to 20 ml.

Further, the number of doses contained in the container 3 and/or thetotal volume of the fluid 2 contained in the container 3 can varydepending on the fluid 2 or respective medicament and/or depending onthe container 3 and/or depending on the necessary medication or thelike.

Preferably, the container 3 can be replaced or exchanged, wherein thetotal number of uses of the nebulizer 1 and thus the number ofcontainers 3, which can be used with the same nebulizer 1, is preferablyrestricted, e.g. to a total number of four or five containers 3. WO2012/162305 A1 discloses additionally such a restriction to the totalnumbers of containers 3 which can be used with the same nebulizer 1.

The container 3 is preferably substantially cylindrical orcartridge-shaped and once the nebulizer 1 has been opened the container3 can be inserted therein preferably from below and changed if desired.It is preferably of rigid construction, the fluid 2 in particular beingheld in a collapsible bag 4 in the container 3. In particular, thecontainer 3 comprises a venting opening or hole 23 which is openedbefore or during first use.

The nebulizer 1 comprises a delivery mechanism, preferably a pressuregenerator 5, for conveying and nebulizing the fluid 2, particularly in apreset and optionally in an adjustable dosage amount.

The nebulizer 1 or pressure generator 5 comprises preferably a holder 6for releasable holding of the container 3, a drive spring 7 associatedto the holder 6, only partly shown, and/or a blocking element 8preferably in form of or with a button for preferably manual actuationor depressing. The blocking element 8 can catch and block the holder 6and can be manually operated to release the holder 6 allowing drivespring 7 to expand.

The nebulizer 1 or pressure generator 5 comprises preferably a conveyingelement, such as a conveying tube 9, a non-return valve 10, a pressurechamber 11 and/or a nozzle 12 for nebulizing the fluid 2 into amouthpiece 13.

The completely inserted container 3 is fixed or held in the nebulizer 1via the holder 6 such that the conveying element fluidically connectsthe container 3 to the nebulizer 1 or pressure generator 5. Preferably,the conveying tube 9 penetrates into the container 3.

The nebulizer 1 or holder 6 is preferably constructed so that thecontainer 3 can be exchanged.

When the drive spring 7 is axially tensioned in the tensioning process,the holder 6 with the container 3 and the conveying tube 9 are moveddownwards in the drawings and fluid 2 is sucked out of the container 3into the pressure chamber 11 of the pressure generator 5 through thenon-return valve 10. In this state, the holder 6 is caught by theblocking element 8 so that the drive spring 7 is kept compressed. Then,the nebulizer 1 is in the tensioned state.

During the subsequent relaxation in the nebulization process afteractuation or pressing of the blocking element 8 the fluid 2 in thepressure chamber 11 is put under pressure as the conveying tube 9 withits now closed non-return valve 10 is moved back in the pressure chamber11, here in the drawings upwards, by the relaxation or force of thedrive spring 7 and now acts as a pressing ram or piston. This pressureforces the fluid 2 through the nozzle 12, whereupon it is nebulized intothe aerosol 14, as shown in FIG. 1, and, thus, dispensed.

Generally, the nebulizer 1 operates with a spring pressure of 5 to 200MPa, preferably 10 to 100 MPa on the fluid 2, and/or with a volume offluid 2 delivered per stroke of 10 to 50 μl, preferably 10 to 20 μl,most preferably about 15 μl. The fluid 2 is converted into or nebulizedas aerosol 14, the droplets of which have an aerodynamic diameter of upto 20 μm, preferably 3 to 10 μm. Preferably, the generated jet spray hasan angle of 20° to 160°, preferably 80° to 100°. These values also applyto the nebulizer 1 according to the teaching of the present invention asparticularly preferred values.

A user or patient (not shown) can inhale the aerosol 14, preferablywhile an air supply can be sucked into the mouthpiece 13 through atleast one optional air supply opening 15.

The nebulizer 1 comprises preferably a housing 24 and/or (upper) housingpart 16 and optionally a biasing or inner part 17 preferably which isrotatable relative thereto (FIG. 2) and/or has an upper part 17 a and alower part 17 b (FIG. 1).

The nebulizer 1 or housing 24 comprises preferably a (lower) housingpart 18. This part 18 is in particular manually operable, and/orreleasable fixed, particularly fitted or held onto the inner part 17,preferably by means of a retaining element 19.

Preferably, the housing parts 16 and 18 and/or other parts form thehousing 24 of the nebulizer 1.

In order to insert and/or replace the container 3, preferably thehousing 24 can be opened and/or the housing part 18 can be detached fromthe nebulizer 1, inner part 17 or housing 24.

Generally and preferably, the container 3 can be inserted before thehousing 24 is closed and/or before the housing part 18 is connected tothe housing 24. The container 3 may be inserted, opened and/orfluidically connected to the delivery mechanism automatically orsimultaneously when (completely) connecting the housing part 18 to thehousing 24/nebulizer 1 and/or when (completely) closing the housing24/nebulizer 1. Preferably, the container 3 is open or fluidicallyconnected when tensioning the nebulizer 1 for the first time with thecurrent container 3.

Preferably, the nebulizer 1 or drive spring 7 can be manually activatedor tensioned or loaded, in particular by actuation of an actuationmember, here preferably by rotating housing part 18 or any othercomponent.

The actuation member, preferably the housing part 18, can be actuated,here rotated relative to the upper housing part 16, carrying with it ordriving the inner part 17. The inner part 17 acts on a gear ortransmission to transform the rotation in an axial movement. As a resultthe drive spring 7 is tensioned in the axial direction by means of thegear or transmission (not shown) formed between the inner part 17, inparticular its upper part 17 a, and the holder 6 and acting on theholder 6. During tensioning the container 3 is moved axially downwardsuntil the container 3 assumes an end position as shown in FIG. 2. Inthis activated or tensioned state the drive spring 7 is under tensionand can be caught or held by the blocking element 8. During thenebulizing process the container 3 is moved back into its originalposition (non-tensioned position or state shown in FIG. 1) by (the forceof) the drive spring 7. Thus the container 3 executes a lifting orstroke movement during the tensioning process and during the nebulizingprocess.

The housing part 18 preferably forms a cap-like lower housing partand/or fits around or over a lower free end portion of the container 3.As the drive spring 7 is tensioned the container 3 moves with its endportion (further) into the housing part 18 or towards the end facethereof, while an aeration means, such as an axially acting spring 20arranged in the housing part 18, comes in contact with base 21 of thecontainer 3 and pierces the container 3 or a base seal or foil 50thereon with a piercing element 22 when the container 3 makes contactwith it for the first time, to allow air in or aeration, preferably byopening or piercing venting hole 23. The venting hole 23 allows forpressure compensation inside the container 3 when fluid 2 is drawn fromthe container 3 during the actuation of the nebulizer 1.

The nebulizer 1 comprises preferably an indicator device 25, whichcounts in particular actuations of the nebulizer 1, preferably bydetecting its tensioning or the rotation of the inner part 17 relativeto the upper part 16 or housing 24. Preferably, the counter device 25 oran associated locking device 26 locks the nebulizer 1 against (further)actuation or use, e.g. blocks further rotation of the housing part18/inner part 17 and, thus, tensioning of the nebulizer 1 or its drivespring 7 and/or blocks actuation of the blocking element 8, in a lockedstate when a certain number of actuations or operations or dischargeddoses has been reached or exceeded.

In the following and with reference to the further figures, a preferredembodiment of the nebulizer 1, container 3, indicator device 25 and/orlocking device 26 is described and shown according to the invention,wherein primarily important aspects and differences will be describedand the previous aspects, features and explanations apply preferablyadditionally or correspondingly even without repetition.

FIG. 3 shows the nebulizer 1 with the container 3 and indicator device25 according the present invention in a schematic section (longitudinalsection) in the non-tensioned state with completely closed nebulizerhousing 24 and, thus, closed housing part 18, wherein the container 3including the proposed indicator device 25 are inserted into or receivedwithin the nebulizer 1 and/or housing 24.

FIG. 4 shows an enlarged partial section of the encircled part of FIG.3. FIG. 5 shows a perspective view of the section of the nebulizer 1 ofFIG. 3. FIG. 6 shows a partial enlargement of the encircled part of FIG.5.

The nebulizer 1 has preferably a longitudinal form or axis whichcorresponds to the axial direction and/or to the main dispensingdirection and/or to stroke movement of the container 3 during tensioningand dispensing.

In the shown non-tensioned state, the nebulizer 1 or its mouthpiece 13is preferably closed by a mouthpiece cover 27. The mouthpiece cover 27is preferably pivotable to allow opening of the mouthpiece 13 for usingthe nebulizer 1.

Preferably, the indicator device 25 is directly and/or unreleasablysecured or fixed to or connected with the container 3. In particular,the indicator device 25 is associated to a respective container 3. Ifthe container 3 of the nebulizer 1 is replaced, the indicator device 25is necessarily or positively replaced as well.

Preferably, the indicator device 25 is fixedly arranged at the bottom orcontainer base 21 of the container 3 and/or opposite to an outlet orhead 28 of the container 3.

In the present embodiment, the indicator device 25 is preferablydirectly connected to or abuts at an outer case or preferably rigidhousing 29 of the container 3.

Preferably, the indicator device 25 and the container 3 are connected byform-fit and/or snap-fit.

In particular, the indicator device 25 circumvents and/or grips over a(lower or bottom) edge 30 and/or any other protrusion or the like of thecontainer 3. In the present embodiment, the edge 30 is a little bitwider in diameter so that it protrudes radially over the essentiallycylindrical outer form of the side wall of the container 3/containerhousing 29.

The diameter of the indicator device 25 is preferably at leastessentially equal to or slightly greater than the diameter of thecontainer 3 or its edge 30.

The edge 30 is preferably formed between the side wall and the bottom orbase 21 of the container 3 or container housing 29. Preferably, the edge30 is formed by flanging, bordering, bending or crimping or by any othersuitable material-forming process.

The indicator device 25 comprises a housing 31 and/or preferably has anat least essentially cylindrical form.

The indicator device 25 or its housing 31 is preferably attached to thecontainer 3 or its base 21 or housing 29 with an at least essentiallyflat and/or axial side.

The indicator device 25 or its housing 31 comprises preferably a holdingor gripping section 32 for connecting the indicator device 25 with thecontainer 3. Preferably, the gripping section 32 circumvents the edge 30and/or grips around or over the edge 30.

In the present embodiments, the gripping section 32 is preferablyannular and/or grips over the edge 31 at positions distributed over thecircumference of the edge 30 or container 3.

Preferably, the indicator device 25 and the container 3 are connectedwith each other by a snap-fit or click connection. Preferably, thecontainer 3 and the indicator device 25 are connected with each other byaxially snapping one part on the other.

Preferably, the gripping section 32 is sufficiently elastic in radialdirection so that the container 3 can be entered axially with its edge30. In the present embodiment, the gripping section 32 preferablycomprises a respectively inclined insertion face to facilitate insertionof edge 30 into the annular gripping section 32 or betweencircumferentially distributed gripping sections 32.

It has to be noted that other constructional solutions are possible forconnecting the container 3 or its housing 29 with the indicator device25 or its housing 31 or vice versa. In particular, the two parts can beconnected with each other additionally or alternatively by welding,brazing, gluing, screwing, clamping, hot-pressing, or the like.

FIG. 7 shows in a schematic, exploded view the indicator device 25according to the preferred embodiment of the present invention.

The indicator or its housing 31 comprises preferably an upper part 33and a lower part 34.

Preferably, the upper part 33 holds or forms the gripping section 32.

The indicator device 25 comprises preferably an indicator element 35 andan associated actuation element 36 and/or a transmission 40 or gear 41for indexing the indicator element 35 or for causing the indexing of theindicator element 35.

The indicator device 25 is for counting and/or indicating a number ofuses performed or still possible with the respective or associatedcontainer 3. Preferably, the indicator element 35 comprises markings 37,such as one or more symbols, numbers, colored or shaded areas or thelike, for at least roughly indicating the number of uses alreadyperformed with or still possible with the respective container 3. In thepresent embodiment, the indicator element 35 is preferably rotatableand/or comprises a circumferential wall or outer surface with the atleast one marking 37.

The indicator housing 31 comprises preferably a window 31 a, inparticular in the circumferential wall through the relevant marking 37is visible for a user or patient, preferably through the housing part 18which is in particular transparent.

The actuation element 36 comprises preferably an actuation arm 38 which,intern comprises preferably a free or actuation end 39, for direct orindirect actuation or indexing of the indicator element 35. Indexingmeans that the indicator element 35 is moved forward in increments orsteps.

Preferred is an indirect actuation or driving so that the actuationelement 36 or its arm 38 actuates or drives the indicator element 35 viaa transmission 40. In the present embodiment, the transmission 40results in a reduction and/or is realized as a worm device.

The indicator device 25 or transmission 40 comprises preferably a gear41 and/or a worm 42. Most preferably, the worm 42 is directly formed bythe gear 41 so that the gear 41 forms a worm gear and preferablycomprises radially protruding teeth 43 in which at least one convolutionof the worm 42 is formed (compare the horizontal or axial sections ofthe mounted indicator device 25 shown in FIGS. 8 and 9).

The gear 41 comprises preferably an axle, in particular one or more axlesections 44 which may axially protrude on opposite sides as realized inthe present embodiment.

The actuation element 36 causes a rotation of the gear 41 around an axispreferably perpendicular to the direction of movement of the actuationelement 36, the axis preferably being arranged in a horizontal planeidentical or parallel to the plane given by the movement of theactuation element 36.

The gear 41 is rotatably held preferably by the housing 31 or lowerhousing part 34, preferably by two bearing sections 45 of the lower part34. Preferably, the bearing sections 45 comprise recesses for rotatablyholding the axle sections 44. However, other constructional solutionsare possible as well.

The housing 31 or lower part 34 bears preferably the indicator element35 such that it can rotate. In the present embodiment, the lower part 34comprises preferably two bearing portions 46 arranged on opposite radialsides and axially protruding for rotatably bearing the indicator element35. The actuation element 35 and/or transmission 40 are preferablyarranged at least essentially in between the bearing portions 46.

The indicator device 25 comprises preferably an actuation spring 47, inparticular for biasing the actuation element 36 into a preferreddirection and/or for driving the indicator element 35.

FIG. 8 shows in a horizontal or axial section the mounted indicatordevice 25 in an actuated state where the actuation element 36 has beenmoved or pushed sideward, namely starting from the first position shownin FIGS. 3 to 6 towards the left into a second position which is shownin FIG. 8.

FIG. 9 shows in a similar section as FIG. 8 the indicator device 25 in alocked state where the actuation element 36 is in a locked, thirdposition.

It can been seen from FIGS. 8 and 9 that protrusions 60 of the indicatorelement 35 (not shown in FIGS. 8 and 9) extend axially, wherein alwaysat least one protrusion 60 is caught in the worm 42 so that a worm driveis formed between the gear 41 and the indicator element 35. Thus, anyrotation of gear 41 is transformed in a reduced rotation of theindicator element 35. Further, a permanent engagement between the gear41 and the indicator element 35, more precisely between at least oneprotrusion 60 and the worm 42, is ensured. However, other constructionalsolutions or couplings between the gear 41 and the indicator element 35are possible.

FIG. 10 shows the mounted indicator device 25 in a perspective sectionin the initial, first position and state. FIG. 11 shows the indicatordevice 25 in a similar perspective section, but with released actuationelement 36, i.e. just before the locked state is reached.

Preferably, the transmission 40 or gear 41 forms a worm (helical groove)42 with at least one convolution, preferably a with about 1.5 or moreconvolutions, so that always at least one engaging element of theindicator element 35 or of any other transmission component, inparticular the inwardly or axially projecting protrusion 60, engages inthe worm 42. Thus, rotation of the gear 41 around its preferablytransversal axis results in a rotation of the indicator element 35around its preferably longitudinally oriented rotation axis. However,other constructional solutions are possible as well.

Preferably, the teeth 43 are relatively long and/or extend radiallysufficiently so that the protrusions are securely guided within theconvolutions of the worm 42, in between the teeth 43, and that theactuation portion 39 can still move in radial direction between theprotrusion 60 engaging into the won't 42 and the gear 41 in order toactuate or rotate the gear 41 in the desired manner. For this purpose,the actuation portion 39 may engage into respectively deep cut outsbetween the teeth 43 in order to be able to move below the respectiveprojection 60.

The indicator device 25 comprises preferably a piercing part 48 (compareFIGS. 3 to 6).

The piercing part 48 is arranged within the indicator device 25 or itshousing 31.

The piercing part 48 is preferably axially moveable.

The piercing part 48 is preferably moveable such that it can protrudetowards the container 3 and/or can open an aeration opening, preferablythe venting hole 23, of the container 3, in particular by breaking orpiercing a foil 50 covering the venting hole 23.

In the present embodiment, the piecing element 48 comprises preferablyan opening end or tip 49 which can open or pierce the foil 50 coveringthe container base 21; in particular an indention 51 formed in thecontainer 3 or its base 21. Preferably, the indention 51 comprises abreak through which forms the venting hole 23. However, otherconstructional solutions are possible as well.

FIG. 12 shows in a partial enlargement similar to FIG. 4 a lower portionof the nebulizer 1 in an intermediate state after partial tensioning.The indicator device 25 is in an actuated state as shown in FIG. 8(second position).

The nebulizer 1 or housing part 18 comprises preferably a driving part52 for driving or actuating the indicator device 25 when using thenebulizer 1, in particular for actuating the indicator device 25 inresponse to any tensioning of the nebulizer 1 and/or any (axial orstroke-like) movement of the container 3.

Preferably, the driving part 52 is arranged or formed in the housingpart 18, in particular on the axial end face or bottom 53 of the housingpart 18.

Preferably, the driving part 52 is arranged centrally and/or extendsaxially.

Preferably, the driving part 52 is at least substantially cylindricaland/or pin-like or bolt-like.

Preferably, the driving part 52 is held by the housing part 18 and/orintegrally formed by the housing part 18.

In the preferred embodiment, the movement of the container 3 and, thus,of the indicator device 25 during the tensioning (downward movement inthe drawings) and/or during pressurization and dispensing (upwardmovement in the drawings) and/or one or both of the respective endpositions in the non-tensioned state and tensioned state, respectively,can be used for actuating the indicator device 25, i.e. for counting.

Preferably, the relative movement of the container 3 and/or indicatordevice 25 within the nebulizer 1 is used for actuating or triggering theindicator device 25 and/or counting.

When tensioning the nebulizer 1 and/or moving the indicator device 25downwards, the driving part 25 enters or engages through an insertionopening 54 of the indicator device 25 or its housing 31, in particularaxially.

Preferably, the driving part 52 and the insertion opening 54 arearranged centrally and/or axially aligned.

In the present embodiment, the driving part 52 actuates the actuationelement 36, i.e. moves the actuation element 36 from an initial firstposition shown in FIGS. 3 to 6, to an actuated second position shown inFIG. 9.

Preferably, the actuation spring 47 biases the actuation element 36 intothe first position.

In the present embodiment, the actuation element 36 is moveable back andforth between the first and second positions for indexing the indicatorelement 35, in particular for incrementally rotating the gear 41 in onedirection to respectively drive the indicator element 35. As anyrotation of gear 41 is transformed in a reduced rotation of theindicator element 35, thus every movement of the actuation element 36from the first to the second position or vice versa results in amovement of the indicator element 35.

In the present embodiment, the actuation element 36 is moveabletransversally, preferably perpendicularly, to the longitudinal ordispensing direction of the container 3 or nebulizer 1 and/or to thestroke movement of the container 3 and/or indicator device 25.

Preferably, the actuation element 36 is moved from the more centralfirst position radially outwards to the second position, in particularagainst the force of the associated, preferably helical actuation spring47 biasing the actuation element 36 in opposite direction.

In the second position, the actuation element 36 has been moved with itsactuation arm 38 or actuation portion 39 out of engagement with gear 41as indicated in FIGS. 8 and 12.

FIG. 13 shows in a similar enlarged section as FIG. 12 the fullytensioned state.

In the (fully) tensioned state, the container 3, more precisely theaeration opening or venting hole 23, is opened at least when thenebulizer 1 is tensioned with a container 3 for the first time.

Preferably, the opening of the container 3 or venting hole 23 foraeration is realized by piercing or breaking, in particular of foil 50.

The opening or piercing can be affected directly by the driving part 52.Alternatively, the opening or piercing can be effected independentlyfrom the driving part 52, e.g. by means of the aeration spring 20 withthe piercing element 22 similar to the embodiment shown in FIG. 2.Alternatively, as in the present embodiment, the opening or piercing canbe achieved indirectly, preferably via the piercing part 48 which ispreferably actuated by the driving part 52.

Preferably, the piercing part 48 is formed as separate part and/orprovided by the indicator device 25 and/or arranged within the indicatordevice 25.

In the preferred embodiment, the piercing part 48 is held axiallymoveable by a support structure 55 of the indicator device 25, housing31, upper part 32 and/or indicator element 35, as schematicallyindicated in FIGS. 10 and 11.

Preferably, the piercing part 48 and/or the support structure 55 are aone-piece-construction with a further part of the indicator devices 25,e.g. with the indicator element 35 or with the indicator housing 31,especially with the upper part 33 of the indicator housing 31.

Preferably, the piercing part 48, support structure 55 and the furtherpart of the indicator device 25 are made of plastic in an injectionmolding process.

Preferably, the support structure 55 comprises flexible arms or ribs forholding the piercing part 48 axially moveable.

Alternatively the piercing part 48 can be constructed as separate,axially moveable part, which is optionally spring biased in thelongitudinal or axial direction away from the container 3, so that thepiercing tip 49 is retracted from the container 3 in the non-tensionedstate.

It has to be noted that the piercing part 48 is preferably receivedwithin the indicator device 25 or its housing 31, but can protrudeoutwards in the actuated state.

The opening or piercing can be repeated each time the nebulizer 1 istensioned, i.e. each time when the container 3 reaches its end positionin the tensioned state.

The piercing part 48 may be biased into its retracted or initialposition shown in FIGS. 3 to 6, in particular by a preferably integrallyformed biasing arm, spring or the like, preferably by the supportstructure 55.

The piercing part 48 may comprise a compensation portion, such as aflexible arm 56, for compensating any tolerances in axial direction.Such tolerances can occur in particular due to variations duringproduction, in particular variations of the length of the container 3and/or other components, variations of the connections of the container3 with the indicator device 25, variations of the length of theindicator device 25 or its housing 31, variations of the axial positionof the container 3 within the holder 6, and the like. Thus, differentdistances between the free end of driving part 52 and the counter-faceof the piercing element 22 can result. The construction is such that thedriving part 52 and the piercing element 22 cooperate in any case suchthat the desired piercing is ensured.

The compensation portion allows axial compression—here by radial flexingof arms 56—when a predetermined axial force is exceeded in order toavoid any damage of the container 3 and/or any other component of thenebulizer 1. Thus, in the preferred embodiment the driving part 52 firstmoves the piercing part 48 towards the container base 21 into thepiercing position and further axial movement of the driving part 52 iscompensated by the compensation portion, preferably by the flexible arms56 being spread radially outwards, giving way to the tip of the drivingpart 52 for entering a central recess in the piercing part 48 (on theside opposite to the piercing tip 49).

The piercing part 48 comprises preferably at least one axial channel, inparticular one or more axially extending grooves 57 circumferentiallydistributed around the circumference of tip 49, in order to ensureunblocked aeration or venting even if the piercing part 48 sticks orstays in the foil 50 or piercing position.

FIG. 14 shows in a similar enlargement as FIGS. 4, 12 and 13 anintermediate state of the pressurization or dispensing process, i.e.when the container 3 has been moved partially upwards again. In thisstate, the driving part 52 has been withdrawn from the indicator device25 or through the insertion opening 54 partially such that the actuationelement 36 starts to return to its initial or first position due to theforce of the actuation spring 47. Finally, after sufficient withdrawalof the driving part 52, the actuation element 36 returns into the firstposition shown in FIGS. 3 to 6 when the back movement is completed.

The back movement of the container 3 and/or of the actuation element 36actuates preferably the indicator device 25 or gear 41 and/or isdetected or counted. In particular, the actuation element 36 or its aim38 or actuation portion 39 transmits the back movement or movement fromthe second to the first position to the transmission 40. In particular,this movement causes an incremental rotation of gear 41.

Thus, in the present embodiment, the movement of the container 3 and/orindicator device 25 within the nebulizer 1 during dispensing ispreferably used to actuating or triggering the indicator device 25and/or for counting.

In the present embodiment, the actuation arm 38 or its portion 39 abutsagainst one tooth 43 of gear 41 during the back movement and, thus,turns the gear 41 due to the back movement one step further, in thedrawings in clockwise direction.

Preferably, the indicator device 25 comprises a ratchet 58 preventingany counter-rotation of the transmission 40 or gear 41. Into the presentembodiment, the ratchet 58 is formed by a flexible arm extending fromthe housing 31, in particular lower housing part 34, and/or meshing withor engaging into the gear 41 or its teeth 43.

In the end position, i.e. in the non-tensioned state, the driving part52 is preferably further or completely retracted from the indicatordevice 25, the indicator housing 31 and/or insertion opening 54 as shownin FIGS. 3 to 6.

The transmission 40 or gear 41 transforms the actuation, in particularthe (backward) movement of the actuation element 36 or its arm38/actuating portion 39, into an indexing of the indicator element 35.The transmission ratio or transmission function of the transmission 40or gear 41 may be designed or constructed such that a reduction ornon-linear driving or indexing is achieved. In the present embodiment,the transmission 40 or gear 41 forms preferably a worm drive forachieving a desired reduction.

The movement of the actuation element 36—in particular from the firstposition to the second position—results in that the actuation arm 38 orits actuation portion 39 are moved out of engagement with the gear 41,in particular can be pulled over the next tooth 43. Hereby, the awl 38is flexed out. The subsequent movement in opposite direction, i.e. theback movement or movement from the second to the first position, resultsin that the actuation arm 38 or its actuation portion 39 contacts thenext tooth 41 and can transmit the at least essential linear movement ofthe arm 38, more precisely the preferably linear movement of theactuation element 36, into a rotation of the gear 41, more precisely inan indexing of gear 41 by preferably one tooth 43.

Preferably, the teeth 43 are asymmetrical, i.e. comprise differentlyinclined shoulders on one side and the other side in order to facilitateand/or ensure the incremental actuation and movement in only onerotational direction by the back and forth movement and engagement ofthe actuation arm 38.

Preferably, the actuation element 36 is linearly moveable and/or forms asliding carriage.

Preferably, the actuation element 36 is supported and/or held moveablyby the housing 31, in particular lower part 34 of the housing 31.However, other constructional solutions are possible as well.

The actuation spring 47 acts preferably between the housing 31 or lowerpart 34 on one hand and the actuation element 36 on the other hand.

In the present embodiment, the spring 47 is preferably alreadycompressed and/or biased in the first position and/or biases theactuation element 36 such that it at least partially closes or blocksthe insertion opening 54.

Preferably, the actuation element 36 comprises an inclined glidingsurface 59 at its part protecting into or over the insertion opening 32in the first position. This surface 59 is inclined such that theinsertion of the driving part 52, i.e. its axial movement or abutment,is transformed into a transversal or radial movement of the actuationelement 36.

Alternatively or additionally, such a surface 59 can also be formed atthe driving part 52 to achieve the desired transformation of the axialmovement into a transversal or radial movement by means of an inclinedplane.

Therefore, the actuation or rotation of the transmission 40 or gear 41is preferably effected by the force of the actuation spring 47 or anyother pressure or energy store or spring means. This results in theadvantage that no additional force is necessary for driving theindicator device 25 or its indicator element 35. Consequently, thepressurization and dispensing process is not disturbed.

Further, the triggering of the counting or actuation of the transmission40/gear 41 is effected preferably by the pressurization or dispensingprocess or movement, i.e. during the actual dispensing of fluid 2, i.e.usually during actual use or inhalation.

The actuation spring 47 biases the actuation element 36 preferablytowards closing the insertion opening 54.

Usually, the movement of the actuation element 36 is restricted so thatit does not completely close the insertion opening 54 before the lockedstate is reached. This limitation is realized in the present embodimentpreferably via a control means or portion 62 against which a controlpart 63 abuts in particular to restrict the back movement of theactuation element 36 at the first position.

The abutment is shown in particular in FIG. 10. However, otherconstructional solutions are possible as well.

After the number of uses of the nebulizer 1 with the container 3 hasreached or exceeded a predetermined number of uses as detected orregistered by the indicator device 25, a locked state is entered and thenebulizer 1 will be locked against further use with the currentcontainer 3 and/or the container 3 will be locked against further usewith the nebulizer 1.

In particular, the indicator device 25 comprises a blocking part 61which blocks further use of the container 3 and/or closes or blocks theinsertion opening 54 in the locked state as schematically shown in theschematically enlargement of FIG. 15 which shows a similar part as FIGS.4 and 12 to 14. In this shown state, the container 3 has returned to itsnon-tensioned position and the driving part 52 has been retracted fromthe indicator device 25. During the last dispensing or pressurizationprocess, the indicator device 25 has moved the indicator element 35 onestep further and detected or registered that the predetermined number ofuses has been reached or exceeded and, thus, that the locked state shallbe entered.

In the present embodiment, the indicator element 35 comprises preferablya control portion 62 which releases the actuating element 36 fordetection of the locked state which results in locking the nebulizer 1or current container 3 against further use.

Preferably, the control portion 62 comprises a cut out or recess whichallows or initiates movement of the blocking part 61 into a blockingposition. Preferably, the blocking part 61 blocks or closes theinsertion opening 54 in the blocking position, i.e. in the locked state.Preferably the control portion 62 is a wall or ridge on the inside ofthe rotatable indicator element 35.

Preferably, the blocking part 61 is integrated into the indicator device25 or its housing 31.

The blocking part 61 is preferably moveable transversally orperpendicular to the longitudinal or dispensing direction of thecontainer or nebulizer 1 and/or of the direction of stroke movement ofthe container 3.

Preferably, the blocking part 61 blocks the actuation or insertionmovement of the driving part 52, in particular relative to the indicatordevice 25 and/or (sufficient) insertion of the driving part 52.

Preferably, the blocking part 61 is linearly moveable and/or formed by asliding carriage. However, other constructional solutions are possibleas well.

Preferably, the blocking part 61 is biased into its blocking position,in the present embodiment preferably by actuation spring 47 or any othersuitable biasing means.

Preferably, the blocking part 61 closes or blocks the insertion opening54 of the indicator device 25 after the last dose of fluid 2 has beendispensed and when the locked state has been entered or detected. Thisdetection is preferably realized in that the blocking part 61 or anyassociated component, such as control part 63, can pass the controlportion 62 in the locked state, most preferably by spring force, inparticular by the force of actuation spring 47 or the like, asschematically shown in FIG. 11.

Preferably, the blocking part 61 is connected with or formed by theactuation element 36 or vice versa. Most preferably, the blocking part61 forms a wall or side, preferably flat side (preferably the bottomside), of the actuation element 36. However, other constructionalsolutions are possible as well.

In the present embodiment, the actuation element 36 can move in thelocked state from the first position into the third position, i.e.preferably in the opposite direction than the movement into the secondposition.

In the present embodiment, the actuation element 36 can close theinsertion opening 54 preferably completely in the third position(blocking position).

With other words, the blocking position of the blocking part 61corresponds preferably to the third position of the actuation element36.

In the locked state or third position, the actuation element 36 hasmoved with the actuation arm 38 or its portion 39 further in theactuation direction so that the actuation portion 39 has passed theprevious tooth 43 in the rotation direction of gear 41 as indicated inFIG. 15.

Preferably, the actuation element 36 is constructed to block further useof the container 3 in the locked state or third position (blockingposition).

Preferably, the actuation element 36 is moveable back and forth betweenthe first and second position for indexing the indicator element 35 andis moveable into a third position to block further use of the container3 in the locked state.

In particular, the closed indicator device 25 or blocking part 61results in particular in that the container 3 cannot move inside theclosed housing of the nebulizer 1 in the stroke-like fashion aspreviously and as required for normal or further use so that normal useis prevented.

In particular, the locking of the indicator device 25 or insertionopening 54 results in that the nebulizer 1 or housing part 18 is atleast partially opened when the nebulizer 1 is tensioned once more orwhen it is partially tensioned. FIG. 16 shows this state (partiallytensioned nebulizer 1 with partially opened housing part 18) in aschematic, longitudinal section of the nebulizer 1. During thetensioning process the container 3 is moving downwardly together withthe indicator device 25. Starting from the non-tensioned state (upperposition of the container 3), the indicator device 25 abuts soon withits blocking part 61/actuating element 36 against the member usuallyactuating the indicator device 25, here the driving part 52, so that afurther usual downward movement is not possible.

In particular, the blocking part 61 restricts the axial movability ofthe container 3 in the nebulizer 1 in the locked state, preferably bypreventing the driving part 52 from insertion into the indicator device25 or restricting its insertion in the locked state. Due to the forceapplied when tensioning the nebulizer 1 and due to the resulting axialforce in the movement of the container 3, the housing part 18 will bemoved outwards or relative to the nebulizer 1, inner part 17 or upperpart 16 together with the container 3 and indicator device 25 during thefurther tensioning movement in axial direction in the locked state.

The above common downward movement of container 3, indicator device 25and housing part 18 is possible due to a respectively constructedfastening of the housing part 18 at the nebulizer 1. In particular, theretaining force is selected or set such that it can be overcome by thedownward movement of the container 3.

In the present embodiment, the retaining element 19 engages with aretaining nose 64 in a respective retaining recess 65 in the housingpart 18 or vice versa. Thus, substantially an indention can be realized.However, the abutting shoulders which extend at least essentiallyradially of the nose 64 on one hand and the recess 65 on the other handare slightly inclined, preferably by about 1° to 5° to the radial planesuch that the axial force of the tensioning process can overcome theretaining force provided by the engagement of the nose 64 into therecess 65 so that the retaining element 19 is flexed radially and theretaining engagement is overcome. Consequently, the housing part 18 ismoved downwardly as well and, thus, is pushed at least partly from thenebulizer 1 or separated from the upper housing part 16 and/or pushedfrom the inner part 17.

This pushing or axial displacement of the housing part 18 or any otheropening of the nebulizer 1 results preferably in that the nebulizer 1 islocked against further use by means of the locking device 26. Therefore,the indicator device 25 or its blocking part 61 indirectly effectsindirectly via the opening of the nebulizer 1 the desired locking of thenebulizer 1 in the locked state.

In the preferred embodiment, the locking device 26 blocks tensioning ofthe nebulizer 1 in the locked state.

Preferably, the locking device 26 comprises a moveable locking element66 and an associated locking spring 67. The locking element 66 ispreferably axially moveable between a locked position and an unlockedposition. The locking element 66 is preferably biased into the lockedposition by the locking spring 67.

In the locked position, the locking element 66 is preferably in itslower axial position shown in FIG. 16. FIG. 17 shows an enlargement ofthe encircled area of FIG. 16.

In the locked position, the locking element 66 blocks rotation of theinner part 17 relative to the outer part 16 and, thus, blocks (further)tensioning of the nebulizer 1. This is preferably achieved in thepresent embodiment in that the locking element 66 moves or engagespreferably axially into a respective pocket 68 formed in the upper part16 such that said relative rotation is blocked. In particular, thelocking element 66 engages with an engagement portion 69 into therespective recess or pocket 68 such that any further rotation and/orback rotation is prevented. However, other constructional solutions arepossible as well.

The locking device 26, in particular the locking element 66 and thelocking spring 67, are preferably arranged and/or supported by the innerpart 17 and/or extend between the inner part 17 and upper part 16.

The nebulizer 1, inner part 17 or locking device 26 comprises preferablya cover 70 covering the locking device 26 at least on the periphery ofthe lower part 17 b of the inner part 17 in order to prevent or at leastcomplicate any undesired manipulation of the locking device 26 orlocking element 66 by a user or patient.

FIG. 18 shows the nebulizer 1 in a similar schematic section as FIG. 16,however with the locking device 26 in the unlocked position, i.e. thelocking element 66 in the upper position. The locking device 26 orlocking element 66 is brought into this position or unlocked preferablyonly by closing the nebulizer 1, in particular by the housing part 18 inthe completely attached or closed position.

In the shown embodiment, the housing part 18 comprises a preferablyfinger-like and/or axially extending actuator 71 which extends into thelocking device 66 and/or into the cover 70 and/or axially abuts and/orpushes the locking element 66 into its unlocking position (upperposition), as shown in FIG. 18. Thus, only the completely closednebulizer 1 or housing part 18 unlocks the locking device 26 and, thus,unlocks the nebulizer 1.

The actuator 71 is preferably arranged within the housing part 18 sothat any manipulation is not possible or at least complicated.

When the nebulizer 1 is in the locked state and, preferably when thenebulizer 1 or its housing part 18 has been opened partially by the lasttensioning process, any further use of the nebulizer 1 with thecontainer 3 and the indicator device 25 in its locked state is notpossible. The locking device 26 locks preferably automatically.Preferably, the locking spring 67 biases the locking element 66 into thelocking position, so that upon at least partial opening of the nebulizer1 or (axial) displacement of its housing part 18, the locking device 26or its locking element 66 can move and moves into the locking position.

Preferably, the locking element 66 is moveable (essentially or only) inaxial direction.

After replacement of the current container 3 with its locked indicatordevice 25 (blocking part 61 in the blocking position) against a newcontainer 3 including a new or reset indicator device 25, the nebulizer1 or its housing part 18 can be closed completely again. Thus, thenebulizer 1 or its locking device 26 can be or is unlocked again.Preferably, the actuator 71 pushes the locking element 66 back into itsunlocking position.

Thus, the locking device 26 is reset or unlocked again, preferably by(completely) closing the nebulizer 1, its housing 24 or housing part 18,and the nebulizer 1 can be used with the new container 3 as previously.

It has to be noted that the insertion opening 54, which is preferablyarranged centrally and/or opens in axial direction and/or allows axialinsertion of an actuator element, in particular the driving part 52 inthe present embodiment, can also be formed as a recess, groove,indention or the like and/or can be arranged at any position or locationat the indicator device 25 with any orientation.

Alternatively, the insertion opening 54 or its closing can also beomitted. Instead, the indicator device 25, actuation element 36 orblocking part 61 can more or less directly communicate with or actuatethe locking device 26 or, for example, the retaining element 19 orblocking element 8 in order to cause a direct or indirect locking of thenebulizer 1 or container 3 against further use.

FIG. 19 shows in a schematic section the indicator device 25 accordingto a modified embodiment of the present invention. FIG. 20 shows aperspective view of the section according to FIG. 19.

In the following, only relevant differences are described so that theprevious explanations and aspects apply in addition, in particular inthe same or similar manner, without repetition.

In the modified embodiment, the actuation arm 38 and actuation portion39 do not engage in between the worm drive, i.e. between the gear 41 andthe engaging protrusions 60 of the driven part, here namely theindicator element 35, but engage with or actuate the gear 41 on anotherside or the side opposite the worm drive, here preferably in FIG. 19from below and not from above. In particular, the actuation arm 38extends more or less in a radial plane and/or more or less in a commonplane with the actuation spring 47 and/or blocking part 61 or thesliding carriage part of the actuation element 36.

Preferably, the actuation arm 38 or portion 39 engages with the gear 41on the side opposite the container 3 or gripping section 32.

In the modified embodiment, the indicator device 25 counts preferablywhen the nebulizer 1 is tensioned, i.e. during the tensioning processand not during the dispensing process as provided in the initialembodiment of the present invention.

In particular, the actuation element 36 or its arm 38 drives or rotatesthe transmission 40 or gear 41, when the driving part 52 is insertedinto the indicator device 25, its housing 31 or its insertion opening 54and/or when the actuation element 36 is moved from the first position tothe second position and/or when the actuation element 36 is pushedtransversally by the driving part 52. In the opposite direction, theactuation arm or its actuation portion 39 passes the next tooth 43 ofthe gear 41, i.e. does not drive the gear 41.

In the modified embodiment, the indicator device 25 or counting is notdriven by the force of the actuation spring 47 or any other spring orenergy store, but by the relative movement of the indicator device 25within the nebulizer 1 or by the insertion of an actuator element, suchas the driving part 52. However, other constructional solutions arepossible as well.

In the modified embodiment, the blocking of the carriage/actuationelement 36/locking part 61 to move into the third or locking positionare released during the tensioning when a predetermined number of usesis reached or exceeded. Then, the carriage/actuation element 36/blockingpart 61 abut against the driving part 52 because the counting occursduring the tensioning. When the nebulizer 1 is actuated or when theblocking element 8 is depressed, the nebulizer 1 is triggered and the(last) dose of fluid 2 is nebulized. During this nebulization, thedriving part 52 is removed from the indicator device 25 or insertionopening 54 so that the carriage/actuation element 36/blocking part 61are free to move into the third or locking position due to the force ofthe actuation spring 47 or any other spring means.

During the next tensioning, the nebulizer 1 or its housing 24 or housingpart 18 will be partially opened when the driving part 52 abuts againstthe closed indicator device 25, in particular against thecarriage/actuation element 36/blocking part 61 restricting or closingthe insertion opening 54.

In the previous embodiment, the counting or actuating of the indicatordevice 25 takes place or occurs when dispensing fluid, i.e. when thedriving part 52 is withdrawn from the insertion opening 54. There, thecarriage/actuation element 36/blocking part 61 are released during thelast use of the nebulizer 1 or dispensing, i.e. when moving from thesecond to the first position so that the carriage/actuation element36/blocking part 61 can move further directly into the third orunlocking position. Thus, any later dispensing is not possible.

In both cases, i.e. in the previous embodiment and in the modifiedembodiment, the indicator device 25 blocks full axial orstroke-movability of the container 3 within the nebulizer 1 in thelocked state and/or causes at least partially opening of the nebulizerhousing 24 and/or housing part 18 in the locked state, in particularwhen the nebulizer 1 is tensioned at least partially for the last timewith the current container 3.

Further, the at least partial opening of the nebulizer 1 or its housing24 or housing part 18 results in that the nebulizer 1 is blocked, inparticular cannot be tensioned any further or used any further, with thecurrent container 3.

FIGS. 19 and 20 show the indicator device 26 according to the presentinvention in the non-actuated or initial state and/or with the actuationelement 36 in the first position. The control part 63, which extendspreferably upwards and/or in axial direction, abuts against thepreferably ring-like control portion 62 which is preferably formed by orat the indicator element 35. Preferably, the control portion 62 has aradial distance to the outer wall of the indicator element 35 so thatthe control part 63 can move in between and that the actuation element36 is free to move between the first and second positions, while theabutment of the control part 63 against the control portion 62 preventsmovement of the actuation element 36 from the first position furthertowards the third position and/or further to (complete) closing theinsertion opening 54.

Preferably, the protrusions 60 are dent-like and/or are tapered towardsits free ends.

Preferably, the protrusions 60 are formed on or connected with thecontrol portion 62.

Generally, the insertion opening 54 is provided preferably with aconical surface or edge to facilitate insertion of the driving part 52or the like.

Preferably, the support structure 55 forms or comprises one or moreflexible arms for moveably holding the piercing part 48, preferably inthe center of the indicator device 25 or its housing 31 or a respectiveopening of the housing 31, so that the piercing part 48 is usually heldinside the indicator device 25 but can move and in particular protrudeoutwards and/or towards the container 3 for opening or piercingaeration. However, other constructional solutions are possible.

Generally, the indicator device 25 and the container 3 form aninseparable assembly or unit, which has to be replaced completely afteruse, in particular after reaching the locked state. However, it is alsopossible that the container 3 and indicator device 25 are supplied oroffered as a kit which can be assembled by the use or patient.

Generally, the indicator device 25 cannot be reset after reaching thelocked state so that it cannot be reused. However, it is also possibleto modify the indicator device 25 such that it can be reset and reused.In this case, the indicator device 25 has to be separated from thepresent container 3 and connected with a new (unused) container 3. Mostpreferably, such a container change would automatically reset theindicator device 25.

Generally, the actuation element 36 or blocking part 61 is moveablepreferably linearly, in particular like a sliding carriage. Inparticular, a sliding carriage is formed.

Preferably, the sliding carriage forms a base part of the actuationelement 36 or blocking part 61.

Preferably, the sliding carriage, actuation element 36 or blocking part61 is moveably held by sliding guides 72 on opposite sides, preferablyon opposite sides of the insertion opening 54, as schematically shown inFIGS. 8 and 9. Preferably, the guides 72 are formed by respective railsor the like of the housing 31 or its lower part 34 which grip overrespective edges or base portions 73 of the actuation element 36 orblocking part 61 to form the desired sliding guidance. However, otherconstructional solutions are possible as well.

Instead of the preferably linear or sled-like moveable actuation element36 and/or blocking part 61, any other motion, in particular a radialand/or pivotal movement, is possible, in particular for partially orcompletely closing the insertion opening 54.

Alternatively, the actuation element 36 and/or blocking part 61 can moveoutwards from the indicator device 25 or its housing 31, preferablytransversally and/or at one side of the indicator housing 31 for lockingat least one engagement possibility and/or actuating any other componentin the locked state or for locking the nebulizer 1 and/or container 3.

Alternatively or additionally, the actuation element 36 and/or blockingpart 61 can engage into or abut against a section or contour of thehousing part 18 and/or nebulizer housing 24 or the like in order torestrict or prevent operation or movement in the locked state in orderto block further use of the nebulizer 1 and/or container 3 in the lockedstate.

The actuation element 36 and/or blocking part 61, in particular alsowhen acting radially, are preferably biased by spring 47 or any otherspring means. The spring or spring means can be formed integrally and/orby plastic parts or pieces. Alternatively, a spiral or clock spring orany other spring, such as helical spring 47 or the like, could be usedfor biasing the actuation element 36 and/or blocking part 61, preferablyinto the locked state.

It is also possible that the driving part 52 directly drives or actuatesthe gear 41. In this case, the driving part 52 is preferably elasticallysupported by the housing part 18, in particular via a spring means (notshown), in particular for compensating axial tolerances and/or allowingradial or transversal flexing of the driving part 52. Additionally oralternatively, the driving part 52 may be flexible in order to allowtransversal flexing for engaging with the gear 41 only in one directionof relative axial movement to the gear 41 to rotate the gear 41 only inone rotational direction.

The indicator device 25 can comprise any other counting mechanism, inparticular as described in WO 2009/037085 A1, page 4, line 19 to page10, line 13, which is incorporated herein by reference. Such a countingmechanism can also trigger, release or actuate the actuation element 36and/or blocking part 61. When using this counting mechanism, therotatable indicator element 35 can also release or control the releaseof the carriage, actuation element 36 or blocking part 61 in the lockedstate to move into the third or locking position or close the insertionopening 54.

It is also possible that the carriage or blocking part 61 is independentfrom the counting. In particular, the driving part 52 may engage the hubof the counting mechanism shown in WO 2009/037085 A1 or the like and/ordrive or actuate the indicator device 25 or counting without actuatingthe carriage or blocking part 61. In this case, the functions areseparated. The carriage and/or blocking part 61 are preferably used onlyfor restricting or closing the insertion opening 54 in the locked state,but not for actuating or driving the indicator device 25 of its countingmechanism or transmission 40 or indicator element 35 or the like.

The container 3 or indicator device 25 or insertion opening 54 may beprovided with a protection (not shown), which covers in particular theinsertion opening 54 before the first use.

Preferably, the protection has to be removed before the container 3and/or indicator device 25 can be inserted into the nebulizer 1 orhousing part 18.

Preferably, the protection extends transversally over the indicatordevice 25 or its housing 31 and/or over the container 3 and/or has alarger diameter than the indicator device 25 and/or container 3, inparticular such that it does not fit into the nebulizer 1 or housingpart 18.

Preferably, the protection can be removed only irreversibly, i.e. cannotbe re-connected after removal.

Preferably, the protection covers or closes the insertion opening 54and/or the indicator device 25.

Preferably, the protection is connected to the indicator device 25 orcontainer 3 by form-fit or force-fit and/or by a snap-fit or click-fit.

Preferably, the indicator device 25 or its housing 31 is inseparablyand/or rotationally asymmetrical connected with the container 3 or itshousing 29. This can be realized differently.

FIG. 21 shows in a schematic partial section the container 3 with theassociated indicator device 25. The container 3 or housing 29 isconnected with the indicator device 25 or its housing 31 optionally oradditionally by gluing, in particular by means of glue 74 asschematically indicated in FIG. 21.

The glue 74 may be arranged at the axial end-face or base 21 and/or at acircumferential portion, such as edge 30 or housing 29, of the container3.

In the shown embodiment, the glue 74 is arranged between the grippingsection 32 and the housing 29 or edge 30. However, the gripping section32 is optional and can be omitted. Instead, the indicator device 25 orits housing 31 may comprise an at least essentially flat surface that isconnected, in particular glued, to the container 3 or vice versa.

Preferably, the container 3 and/or indicator device 25 and/or connectionare formed or constructed such that the glue 74 does not flow into theindicator device 25 or its housing 31 and/or into the center and/or intothe venting hole 23. Preferably the container 3 or its base 21 ispreferably tightly pressed onto the indicator housing 31 during theforming of the connection whereby the respective surfaces of container 3and of indicator housing 31 form a stop or seal between the glue 74 andthe venting hole 23 or the center of the indicator device 25.Alternatively an annular stop or seal (for instance formed of suitablepreferably elastomeric material attached onto the indicator housing 31or the container 3 or in form of an additional—preferablyelastomeric—sealing component) may be provided (not shown), inparticular before applying the glue 74.

Preferably, the glue 74 covers the end or end face or base 21 of thecontainer 3 or the radial sides of the container edge 30 and/orindicator housing 31 only in an annular or ring section or partsthereof, e.g. in circumferentially spaced ring sections or the like.

Preferably, the container 3 or its housing 29 is made of metal, inparticular aluminum.

Preferably, the indicator housing 31 is made of plastic, in particularABS or the like.

Preferably, the glue 74 is hardened by radiation or light, in particularlaser light or UV radiation. The hardening by radiation, in particularby radiation with ultraviolet light or laser light, may be used toaccelerate the hardening process of the glue 74 and, thus, to minimizeproduction time.

Preferably, the glue 74 has in its hardened or final (set) statecharacteristics that are similar to the material characteristics of atleast one of the components (for instance of the indicator device 25 orits housing 31), in particular similar to ABS or the like.

Instead of glue 74, any other suitable firm bond can be used to connectthe indicator device 25 with the container 3, such as snapping,clamping, forming or welding or the like, depending on the usedmaterials, stability, ease of production, production costs and the like.It is also possible to provide one or more defined indentions, recessesor the like at the container 3, into which snap hooks of the indicatordevice 25 or its housing 31 can engage in order to realize a form-fitconnection, optionally in combination with a press-fit.

As already mentioned, the glue 74 (which is a connection element formingan adhesive bond or substance-to-substance bond) is optional.Alternatively, the indicator device 25 can be connected with thecontainer 3 by deformation of the gripping section 32, in particular byultrasonic forming or hot-pressing. Without glue 74, FIG. 21 shows thecontainer 3 with associated indicator device 25 before deformationand/or before inward bending of gripping section 32. FIG. 22 shows thecontainer 3 with associated indicator device 25 in a schematic partialsection similar to FIG. 21, wherein the gripping section 32 has beendeformed and/or grips over a portion or edge 30 of container 3 with agreater diameter to preferably connect the container 3 or its housing 29with the indicator device 21 or its housing 31 by form-fit, inparticular form-fit engagement in axial direction. Preferably, thegripping section 32 or a collar on the indicator housing 31, is deformedor bent over the edge 30 or the like by hot-pressing/hot stamping orultrasonic forming or any other suitable process. Preferably, thegripping section 32 is made of plastic.

Preferably, a tool, in particular a heated forming tool (forhot-pressing/hot stamping) or an ultrasonic sonotrode, is movedlongitudinally over the container 3 towards the container base 21, edge30 and/or gripping section 32 and/or connection area, preferably whereinthe heated tool or sonotrode comprises a preferably conical end sectionfor forming the softened gripping section 32 in the desired manner, inparticular towards the container 3 and/or radially inwardly.

Particularly preferable is a connection process employing ultrasonicexcitation and/or a heated forming tool (a “thermode” or hot bar). Inthe ultrasonic excitation process, a sonotrode is used to coupleultrasonic energy into the part (here the gripping section 32) which isformed by the tool shape around the gripping section 32 and which ismade out of plastic. The ultrasonic energy excites molecular vibrationsby which the plastic is softened and/or (partly) melted. The vibrationscan be excited in a longitudinal, transversal, elliptical (longitudinalplus transversal mode) or torsional (rotational mode) way. Thelongitudinal mode creates tensile stress the transversal or rotationalmode shear stress in the induced material. For forming a rotationallysymmetrical part, longitudinal, elliptical or rotational modes can beapplied. An elliptical or torsional mode of vibration is preferred, asit has been shown that a torsional or elliptical excitation can be muchbetter controlled than the longitudinal excitation because a much loweramount of incoupled energy is needed and the ultrasound waves have acomparatively short reach so that the risk of secondary bonds of nearbyparts is much lower.

In a hot stamping or hot pressing process thermal energy is coupleddirectly into the plastic of the part to be form-shaped (the grippingsection 32 in case of the shown embodiment).

When the gripping section 32 or a like collar of the indicator device orof the indicator housing 31 has been sufficiently plastified or softenedor melted by the ultrasonic excitation or transferred thermal energy,the gripping section 32 or the collar is form-shaped or pressedpreferably onto the edge 30 of the container 3 or onto a protrusion onthe container housing 29 or into an indention in the container housing29. After the actual form shaping, the energy input (coupling ofultrasonic or thermal energy into the plastic material/into the grippingsection) is ended and, preferably, the tool which is used for theform-shaping of the gripping section 32 remains in the position itassumed for the form-shaping until the plastic has cooled down (at leastbelow the plastifying or melting temperature) and/or solidified in thenewly shaped form, before the tool is withdrawn from the work piece(container with attached indicator device/indicator housing). Thecooling of the form-shaped plastic or gripping section can beaccelerated by cooling the tool used for the form shaping or by using aform-shaping tool with a (control-able) cooling. Thus the processingtime for attaching the indicator device 25 to the container 3 or housing29 of the container 3 can be reduced.

The connection which results of the form-shaping process involvinghot-pressing/hot stamping or ultrasonic excitation comprises a form-fitbetween the thus beaded or flanged collar or gripping section 32 and thecontainer housing 29. Due to material shrinkage occurring during thecooling/solidification of the plastified/molten material the connectioncould also comprise a force-fit, as well. Thus the indicator device 25or indicator housing 31 is fixed and/or inseparably connected with thecontainer 3 or the container housing 29. Preferably, the connectionachieved by the form-shaping process is a rigid connection in which theconnected components (here the gripping section 32 or indicator housing31 and the container housing 29) are unmovable in relation to eachother, i.e. they cannot be separated and typically they cannot be movedotherwise against each other. In particular, they cannot be rotatedrelative to each other.

The gripping section 32 grips preferably over or into a respectiveundercut, indention or the like in order to realize the preferredform-fit connection between the indicator device 25 or its housing 31and the container 3 or its housing 29.

The gripping section 32 can form a ring and/or can extend continuouslyin circumferential direction. Alternatively, the gripping section 32 canbe interrupted and/or formed by circumferentially distributed portionsor the like. The latter may facilitate the deformation.

Preferably, the container housing 29 comprises a rotationallyasymmetrical, i.e. non-circular, section for engagement with theindicator device 25 or its housing 31 in order to realize the anti-twistsecurement with the indicator housing 31 or vice versa. In particular,this section may comprise an indentation, protrusion, or flattening 75as schematically shown in the perspective view of FIG. 23 wherein thecontainer 3 and indicator device 25 are shown separately beforeassembly.

Preferably, the rotationally asymmetrical section or flattening 75 isformed at the lower end or edge 30 of the container housing 29.

Preferably, the rotationally asymmetrical section comprises an indentionor protrusion or flattening 75 in radial and/or tangential directionand/or forms a non-circular contour.

In the present embodiment, two or more rotationally asymmetricalsections or flattenings 75 are provided, preferably on opposite ordifferent sides and/or circumferentially spaced.

As already mentioned, the container 3 or edge 30 can also be providedwith one or more depressions, recesses, a riffle or any other contourinstead of or in addition to the flattenings 75, preferably made byknurling, into which the gripping section 32 can flow or engage whensoftened or melted during the preferred hot pressing or ultrasonicforming. This enhances the inseparability and/or relative immovabilityof the container 3 and the indicator device 25.

Preferably, the container 3 and the indicator device 25 can be connectedwith each other in any rotational position to each other.

The indicator device 25 or its housing 31 or gripping section 32comprises preferably at least one engagement section 76 for engagementwith or into the rotationally asymmetrical section or flattening 75 orthe like, wherein the engagement section 76 preferably abbots againstthe rotationally asymmetrical section or flattening 75.

Preferably, the rotationally asymmetrical section or engagement 75 andthe engagement section 76 engage such that a firm rotational connectionis formed between the container 3 or its housing 29 on one hand and theindicator device 25 or its housing 31 on the other hand, preferably byform-fit engagement.

In the shown embodiment, engagement section 76 is preferably formed by aradial inwardly protruding projection or shoulder, preferably formed bythe indicator housing 31 or gripping section 32. However, the engagementportion 76 can also be formed directly by a respective deformation ofthe gripping section 32 or the like.

Preferably, two or more engagement sections 76 are provided or formedfor form-fit engagement with respective rotationally asymmetricalsections or flattenings 75 as indicated in the schematically radialsection of FIG. 24 along line XXIV-XXIV of FIG. 22.

However, other constructional solutions are possible as well in order torealize the desired non-rotational connection of the indicator device 25in container 3.

Further, it has to be considered that even a small rotational playbetween the container 3 and the indicator device 25 may be regarded as apreferred non-rotational connection of the container 3 with theindicator device 25 or vice versa.

Thus, the housing 31 of the indicator device 25 is secured againstrotation relative to the housing 29 of the container 3 preferably byform-fit engagement or firm bond as explained above.

The anti-twist securement of the container 3 with the indicator device25 can be realized by the form-fit engagement as described above and/orby gluing of both parts together. Further, it is possible to use theform-fit engagement for anti-twist securement in combination withanother connection, such as by gluing, for axial securing or connectingthe container 3 with the indicator device 25 or vice versa.

Preferably, the indicator device 25 or its housing 31 may be used orgrabbed by a user (not shown) to detach the container 3 form thenebulizer 1 (in particular for container replacement), in particular fordetaching the container head 28 from the holder 6 after opening ordetaching the housing part 18. In particular, the user rotates and/oraxially pulls the indicator device 25 or its housing 31, and, thus, candetach the container 3 from the nebulizer 1 or holder 6. Due to theanti-twist securement of the container 3 and the indicator device 25,the user can preferably rotate the container 3 (via the indicator device25) relatively to the conveying tube 9 or nebulizer 1 and thus diminishthe adhesion between the container head 28 and the conveying tube 9.Thus the drag forces necessary to take the container 3 out of thenebulizer 1 or to pull the container head 28 away from the conveyingtube 9 are diminished, i.e. an exchange of the container 3 isfacilitated.

Then, the container 3 can be preferably axially withdrawn from thenebulizer 1 and, if desired, replaced by a new container 3 together withan associated new indicator device 25.

Preferably the indicator device 25 or its housing 31 or container 3comprises at least one griping portion to facilitate grabbing, inparticular of the indicator device 25 or its housing 31. Preferably, thegriping portion comprises at least one flattening, riffle 77, indention78 and/or projection 79 as schematically indicated in FIG. 25 whichshows the container 3 and connected indicator device 25 in a side view.

In the shown embodiment, the indicator device 25 comprises preferablytwo riffles 77 on opposite sides as schematically shown in FIG. 24.

Preferably, the gripping portion is located at a circumferential wall ofthe indicator housing 31 and/or on the lower end-face or part 34 of theindicator device 25.

However, the gripping portion could be arranged or fixed alternativelyor additionally on the container 3, its base 21 or edge 30 independentlyfrom the indicator device 25.

Thus, the gripping portion can be used in any case to more easily detachthe container 3 from the nebulizer 1 or holder 6 independently from theprovision of the indicator device 25.

As already mentioned, individual features, aspects and/or principles ofthe embodiments described may also be combined with one another asdesired and may be used particularly in the shown nebulizers 1 but alsoin similar or different nebulizers.

Features of the different embodiments can be combined or exchanged.

Unlike freestanding equipment or the like the proposed nebulizer 1 ispreferably designed to be portable and in particular is a mobile handoperated device.

The proposed solution may, however, be used not only in the nebulizers 1specifically described here but also in other nebulizers or inhalers,e.g. powder inhalers or so-called metered dose inhalers.

Preferably, the fluid 2 is a liquid, as already mentioned, especially anaqueous pharmaceutical formulation or an ethanolic pharmaceuticalformulation. However, it may also be some other pharmaceuticalformulation, a suspension or the like.

According to an alternative embodiment the fluid 2 may also compriseparticles or powder. In this case, instead of the expulsion nozzle 12,some other kind of supply device may be provided, especially anexpulsion opening (not shown) or a supply channel (not shown) forsupplying the fluid to or powder or the like into the mouthpiece 13. Theoptional air supply opening 15 then serves to supply ambient airpreferably in parallel so as to general or allow an airflow with asufficient volume for breathing in or inhaling through the mouthpiece13.

If necessary the fluid 2 may also be atomized by means of a propellantgas.

Preferred ingredients and/or formulations of the preferably medicinalfluid 2 are listed in particular in WO 2009/115200 A1, preferably onpages 25 to 40, or in EP 2 614 848 A1, paragraphs 0040 to 0087, whichare incorporated herewith by reference. In particular, these may beaqueous or non-aqueous solutions, mixtures, formulations containingethanol or free from any solvent, or the like.

LIST OF REFERENCE NUMERALS

-   1 nebulizer-   2 fluid-   3 container-   4 bag-   5 pressure generator-   6 holder-   7 drive spring-   8 blocking element-   9 conveying tube-   10 non-return valve-   11 pressure chamber-   12 nozzle-   13 mouthpiece-   14 aerosol-   15 air supply opening-   16 upper housing part-   17 inner part-   17 a upper part of inner part-   17 b lower part of inner part-   18 housing part (lower part)-   19 retaining element-   20 aeration spring-   21 container base-   22 piercing element-   23 venting hole-   24 nebulizer housing-   25 indicator device-   26 locking device-   27 mouthpiece cover-   28 head-   29 container housing-   30 container edge-   31 indicator housing-   31 a window-   32 gripping section-   33 upper part-   34 lower part-   35 indicator element-   36 actuation element-   37 marking-   38 actuation arm-   39 actuation portion-   40 transmission-   41 gear-   42 worm-   43 tooth-   44 axle section-   45 bearing section-   46 bearing portion-   47 actuation spring-   48 piercing part-   49 piercing tip-   50 foil-   51 indention-   52 driving part-   53 bottom-   54 insertion opening-   55 support structure-   56 flexible arm-   57 groove-   58 ratchet-   59 surface-   60 protrusion-   61 blocking part-   62 control portion-   63 control part-   64 retaining nose-   65 retaining recess-   66 locking element-   67 locking spring-   68 pocket-   69 engagement portion-   70 cover-   71 actuator-   72 sliding guide-   73 base portion-   74 glue-   75 flattening-   76 engagement section-   77 riffle-   78 indentation-   79 projection

What is claimed is:
 1. A container (3) for a nebulizer (1), thecontainer (3) containing a fluid (2), and the container (3) comprisingan indicator device (25) for at least one of counting, indicating anumber of uses performed, and indicating a number of uses still possiblewith the container (3), wherein the indicator device (25) comprises anindicator housing (31) which is inseparably connected with a housing(29) of the container (3) opposite to at least one of an outlet and ahead (28) of the container (3); wherein at least one of the indicatordevice (25) and the indicator housing (31) is connected via anultrasonic weld with the container (3), and wherein the housing (29) ofthe container (3) comprises a rotationally asymmetrical section,including at least one of an indentation, a protrusion, and a flattening(75), to secure the indicator housing (31) against rotation relative tothe housing (29) of the container (3).
 2. The container (3) according toclaim 1, wherein the indicator device (25) is fixedly arranged at a base(21) of the container (3).
 3. The container (3) according to claim 1,wherein the indicator housing (31) is secured against rotation relativeto the housing (29) of the container (3).
 4. The container (3) accordingto claim 1, wherein at least one of the indicator device (25) and theindicator housing (31) comprises at least one of a riffle (77), anindention 78, and a projection
 79. 5. A container (3) containing a fluid(2), comprising: a nebulizer housing (24) for receiving the container(3); an indicator device (25) for at least one of counting, indicating anumber of uses performed, and indicating a number of uses still possiblewith the container (3); wherein: the container (3) is moveable axiallywithin the closed nebulizer housing (24) during nebulization, theindicator device (25) comprises an indicator housing (31) which isinseparably connected with a housing (29) of the container (3), butseparable from the nebulizer housing (24), so that the indicator device(25) is replaceable together with the container (3), and at least one ofthe indicator device (25) and the indicator housing (31) comprises agripping portion, including at least one of a flattening, a riffle (77),an indention (78), and a projection (79), and the housing (29) of thecontainer (3) comprises a rotationally asymmetrical section, includingat least one of an indentation, a protrusion, and a flattening (75), tosecure the indicator housing (31) against rotation relative to thehousing (29) of the container (3).
 6. The container (3) for thenebulizer (1) according to claim 5, wherein the indicator device (25) isfixedly arranged at a base (21) of the container (3).
 7. The container(3) for the nebulizer (1) according to claim 5, wherein at least one ofthe indicator device (25) and the indicator housing (31) is connected bygluing with the container (3).
 8. The container (3) for the nebulizer(1) according to claim 5, wherein the indicator device (25) is connectedby at least one of hot-pressing and welding with the container (3).